Blood handling apparatus



Ap 7, 1964 D. BELLAMY, JR., ETAL 3,127,892

A BLOOD HANDLING APPARATUS Filed July 13, 1960 4 Sheets-Sheet l INVENTORS DAVID BELLAMY, JR. EDWARD SOHIER WELCH, JR.

ATTORNEYS April 1964 D. BELLAMY, JR.. ETAL 3,127,892

BLOOD HANDLING APPARATUS Filed July 13', 1960 I 4 Sheets-Sheet-2 INVENWRS' DAVID BELLAMY, an. EDWARD SOHIER WELCH, JR.

BYIBM' f 1 ATTORNEYS April 7, 1964 D. BELLAMY, JR.. ETAL' 3,127,892

I BLOOD HANDLING APPARATUS Filed July 15, 1960 4 Sheets-Sheei :s

INVENTORS 46 F l G. IO DAVID BELLAMY an.

sowg r zo SOHIER wpclmm. W fiflza wumfff i ATTORNEYS April 7, 1964 D. BELLAMY, JR., ETAL 3,127,892

BLOOD HANDLING APPARATUS 4 Sheets-Sheet 4 Filed July 13, 1960 I I. I. I. I. I. I. I:-

u vggrozzs EBDYWARD SOHIER 'wELoH,JR.

and I DAVID BELLAM ATTORNEYS United States Patent 3,127,892 BLOOD HANDLING APPARATUS David Beliamy, In, and Edward dohier Welch, Lin, Framingham, Mass, assignors, by mesue assignments, to Baxter Laboratories, ind, Morton Grove, IlL, a corporation of Delaware Filed July 13, 1960, Ser. No. 42,691 5 Claims. (Cl. 128-414) This application relates generally to blood handling technique and equipment and more particularly to method and apparatus for the safe sterile collection and storage of separate donations and sample volumes of the blood. The invention provides for collecting a blood donation into a storage container in sterile manner and through an integral donor tube, and, continuously with that donation collecting, for the obtaining of a sample thereof through the same donor tube into a separate sample chamber substantially without violating the closed system and with minimum risk of contamination of the blood or of infection of the operator.

The invention will be better understood from a consideration of the following specification taken in conjunction with the accompanying drawings in which FIG. 1 is an assembly view of one form of the invention apparatus and showing schematically the integralseparable donor tube coupling;

FIGS. 26 are sectional views of several alternative em. bodiments of the donor tube coupling of the invention;

FIG. 7 is an exploded perspective of the FIG. 6 form;

FIGS. 8 and 9 are sectional and perspective views of a modification of the form of FIG. 6-;

FIG. 10 is a section of another form of the invention coupling;

FIG. 11 is a section of yet another form of the same;

FIGS. 12 and 13 show the manipulation of the FIG. 11 form in accordance with the invention; and

FIGS. 14 and 15 further illustrate the donation and sample handling apparatus and manipulation of the invention.

In the handling and more particularly the collecting, storing, and administering of human whole blood it is necessary with each blood donation to obtain separately a number of pilot blood samples for required laboratory tests, as serological, group and type, and cross-matching tests. These tests may be and commonly are carried out by different agencies. Thus the agency for collecting the blood may be required to perform serological,

grouping and typing tests on the blood, while the transfusion agency may be required to conduct cross-matching and culturing tests. This testing by different agencies at different times and places and for different purposes will be understood generally to require at least two pilot samples, and to call for different sample chambers each specifically designed for its particular type of test.

The herein concerned dividing and storing of a unit or single blood collection in separate donation and sample volumes is sought to be carried out in simple or safe and sterile or contamination-free manner. The sample is desired to be positively and lastingly identified with but accessible without exposure of the donation. And the collection of the separate donation and sample volumes is ideally to be carried out in an integral closed system without entry or opening into such system which exposes either the attendant or the blood to contamination, or which risks alteration of the blood.

In the prior practice with glass blood-storing equipment there was utilized for obtaining the separate parent and pilot sample collections a single unitary length of donor or collecting tube initially separate from the ice equipment and mounting a phlebotomy needle at one end and another rigid cannula, such as a flask needle, at the other. In effecting the parent collection the phlebotomy needle was applied to the blood donor and the flask needle inserted in a glass bottle which had been evacuated and closed by a cannula-pierceable self-sealing stopper. For the sample collection the flask needle was withdrawn from the bottle and reinserted into a separate pilot-sample chamber or tube having a similar cannulapierceable, self-sealing closure.

With the necessary use as described of a separate donor tube the glass bottle technique was disadvantaged by a double possibility of contamination, in that the fluid path of the donor set was exposed once for the insertion of the flask needle in the bottle and then again a second time for the insertion of phlebotomy in the donors vein.

With the more recently introduced plastic blood and solution handling equipment there has been provided a collecting or donor tube integrally joined to a storage bag, whereby the main donation is collected into a truly closed system, and the initial one of the aforementioned two or more possibly contaminating needle exposures and insertions is eliminated. But in the prior technique with such integral plastic bag and tube apparatus, and at least to obtain pilot samples of relatively large volume, the equipment was manipulated in open manner, i.e. the pilot samples were obtained from open blood.

In the prior manipulation more particularly of the plastic apparatus the integral donor tube was severed or cut following collection of the main donation, after first clamping or otherwise closing the tube permanently below and temporarily above the cut. With the phlebotomy needle left undisturbed in the donors vein, the stub of the donor tube was then carried to and inserted in an unstoppered pilot chamber, where upon the temporary clamp above the cut was released to allow the sample collection to proceed. It will be obvious that this described opening up by cutting of the donor tube and collecting of the pilot sample into an open tube both exposed the blood to possible contamination or alteration and subjected the attendant to risk of infection.

This invention provides novel method and means for the safe, sterile collection of pilot samples in any quantities to the limit volumetrically of the sample chamber and physiologically of the blood donor. The improved blood-handling technique and apparatus of the invention will be understood more particularly to combine the advantages of the glass bottle and separate donor tube equipment in respect to the simplicity and ease of handling the samples with the advantages of the plastic bag and integral donor tube equipment in respect to the obtaining of samples with safety and minimal chance of contamina tion such as is required for cross-matching and culturing purposes. Specifically the invention assures the complete identity of the sample and donation volumes and by their collection through the same route and subjection to the same hazards of contamination.

The blood handling means or apparatus of the invention novelly provides an integral-separable donor tube in which a coupler cannula or needle is initially sealingly installed or enclosed in and as the flow path of some length of the tube. The invention donor tube is characterized also as both initially integral and readily separable at such cannula enclosing length, and more particularly as manually manipulable to withdraw and expose the coupler needle for application to and piercing insertion through the stopper of a pilot tube.

In FIG. 1 is shown a blood collecting, storing, and sampling apparatus comprising a flexible elastic plastic collecting or donor tube indicated generally at 20 and 3 presenting an upper length 21 mounting a phlebotomy needle 22 having a manipulating hub 22a to which the end of the tube 22 is seized and a stern 22b projecting for insertion into the vein of a donor, conveniently in the arm as shown.

Integrally-separably joined to the upper length 21 is a lower donor tube length 23 inletting to and more particularly integrally joined to and opening at its lower end through a wall of a collapsible blood storage bag 24. The construction of the bag 24 and of the attachment of the tube 23 thereto may be of any known or convenient form, for example that fully described in Walter Patent No. 2,702,034. And as therein also specified the bag 24 and tube 2% apparatus hereof may be and preferably is constructed of a tough, transparent, sterilizable, and hemorepellent plastic such as polyvinyl chloride.

In accordance with the invention internally located means may be provided for initially closing the tube 2% at the inner end or proximal to the bag 24, and which means are removable and may also be insertible from without and without entering the system. Such tube inner end closing means will be understood to close and seal any initially charged fluid in the bag, as when the tube outer end is opened.

As shown in FIG. 1 the described self-contained externally manipulable means for removably closing and sealing between the bag and tube comprises a hard ball or bead 25, which may be steel, and which is made or coated to be hemorepellent. The bead 25 is also oversizes, whereby upon inserting it will be frictionally held or lodged in the tube in the region of or adjacent the bag 24, and requires for blood collecting to be forced or expressed down into the bag 24 by squeezing or milking of the lower tube length 23 as hereinafter to be mentioned.

Referring now again to the cross-matching of the blood, that test is a final clearance technique to assure compatibility of the donors with the recipients blood, and will be understood to require absolute and unmistakable identity of the pilot sample with its parent donation. And for significant or valid results in connection also with the mentioned culturing tests, it is equally necessary to those that the sample blood pass through the same route as and be exposed to the same hazards of contamination as the main donation.

Thus the sample blood for the cross-matching and culturing tests ideally should be, and under this invention may be, taken from the donor or collecting tube as provided and retained integral with the storage bag.

As shown in FIG. 1 and more particularly in FIG. a plurality of like identifying markings or symbol formations 27 are integrally raised or recessed at and to physically modify the tube length 23, and intermediate said symbol formations 27 Xs or other suitable markings or demarcations 28 are applied in the similar physically modifying manner at segmenting intervals, whereby to condition the tube for dividing by closing and sealing at said demarcations 28 into a plurality of individually sealed aliquot or sample storing segments or tubes which are positively and lastingly identified, and by their marking in manufacture also correctly related or matched one with the other and with the main donation.

In accordance with the invention an aliquot or sample marking is applied to the collecting tube segment immediately adjacent or proximal to the bag 24, and that is retained with the bag and whereby its marking serves to identify the main or parent donation. The additional aliquot storing segments marked oif along the tube 23 as between the demarcations or Xs 28 will be understood to have the same identical identifying symbol formations 27, as are conveniently applied by a continuous marking operation.

The integral donor collecting tube hereof comprises further the novel integral-separable coupling schematical- 1y shown at 30 in FIG. 1, and of which are shown in the other drawing figures the several embodiments now to be considered.

In FIG. 2 the integral-separable donor tube is shown as comprising at the coupling 30 a cannula or stiff tube 31 of steel or the like and proportioned as shown to fit snugly or closely within the donor tube. The cannula 31 is seen as beveled or otherwise shaped at one end to present there a puncturing or piercing point 32. It may also, and conformantly with the system as a whole, be formed or coated at least at its bore or lumen to present to the blood a hemorepellent surface.

In the FIG. 2 embodiment also the donor tube 20 is seen as formed or fused to be unitary or integral through the intermediate coupling 30, but conditioned there for manual separation or pulling apart of the same and to withdraw from or expose the cannula point 32 while retaining the cannula end 33 distal thereto seated in the upper tube length 21. The integral tube 20 of FIG. 2 may be variously conditioned for its said pulling apart, as by interrupting or otherwise weakening its wall, for example by a peripheral recess 34. Various means are likewise available for adhering the cannula 31 or more particularly its unpointed end 33 in upper tube length 21, as herein by a metal-plastic cementing coating 35 applied to one or the other or both of said cannula end and tube length.

Further to the FIG. 2 coupling, the tube 20 has a freely sliding fit over the cannula 31 so that the manual pulling apart of the upper and lower tube lengths 21, 23 with a strength to break the integral-separable coupling, as at recess 34, will suffice to pull the lower tube length 23 away from the cannula 31, and so expose the piercing point 32 similarly as are shown to be exposed the coupler or cannula points of FIGS. 7 and 13.

In FIG. 3 is shown an alternative embodiment which departs from that of FIG. 2 in that the donor tube 20 is initially formed as separate lengths 21, 23, whereby the cannula 31 is conveniently first seized at its unpointed end 33 in tube upper tube length 21, as by cementing 35, and the lower tube length 23 then drawn over the projecting or pointed cannula end 32 and closed or butted to the upper tube length 21 as shown. The said closed or \b-u-tted ends of the tube length 21, 23 are then integrally joined or sealed, as by a band or ring of sealant 36, in a manner or with a strength to permit their manual pulling apart or separating similarly as described for the FIG. 2 form. The ealant 36 qualifies the FIG. 3 form as equally tamper-proof as the integral tube of FIG. 2, in that when broken it affords a visual indication or telltale that the system has been opened, by any said pulling apart of the donor tube.

In either of the FIGS. 2 and 3 forms the integral-separable donor tube hereof may comprise also an integral puncturable membrane or diaphragm 37, FIG. 3, atfording a fluid tight closure of the lower tube length 23 and at a point initially proximate the cannula 31. Further, the donor tube may be formed at least at the end of the lower tube length 23 as deformable and exipandible such that it maybe collapsed lengthwise into reverse folds 38, FIG. 4. With this construction the lower tube length 23, which is initially closed by diaphragm 37, is axially closed or collapsed over the cannula point 32 suifieiently to cause or advance that to pierce diaphragm 37 as shown in FIG. 4, and thereby to open tube length 23 and more generally the donor tube 20 to the initial blood collection.

In the FIG. 5 form the lower tube length 23 mounts a diaphragm 39 and is closed also by a rubber or other elastomeric, self-sealing insert or plug 40 seized in the tube end and seated proximal to the diaphragm as shown. With the use of such inserted self-sealing closure it will be convenient to space the tube lengths 21, 23 apart as by a rubber or other elastomeric sleeve 41 which is both radially expandible and axially collapsible, and has its opposite ends expanded and sealingly engaged over the proximate ends of the said tube lengths 21, 23. Thus the sleeve 4'1 protectively encloses and seals against bacterial contamination the projecting cannula point 3-2, the extremity of which may be initially and protectively inserted partway in the plug 4% as shown.

The closing or collapsing manipulation of the FIG. 5 form may serve to close or collapse the sleeve 41 in folds like those shown at 3% for the tube length 23 of FIG. 4, or if as optionally the tube il was stressed or elongated in the initial assembly it may merely be relaxed, upon the advancing of the cannula point 32 through plug 40 and also diaphragm 39 to open the collecting tube Zll.

Further to the FIG. 5 form, it will be seen that the pulling apart of the tube lengths Zll, 23 as following the blood collection, will reclose lower length 23 by the selfsealing of plug 4%) upon the withdrawal. So that in the FIG. 5 and similar forms the donor tube has a self-sealing closure of its lower length or inner end. It may be noted also that the sleeve 41 may be grasped at, or be more firmly secured to, the lower length 23 so that it will be pulled off upper length 21 by the described se arating of the donor tube. Of course the FIG. 5 form may at any desired time be manipulated \as described to reclose the lumen or passage of without continuing the separating of the lengths of and to break the integral sealed coupling of the collecting tube. In other words the sleeve 41 may simply be returned by unfolding or restoring to the initial position shown in the drawing.

It is here pointed out that while preferably intermediate as herein the coupling 30 and its closure means such as the diaphragm 37, or the diaphragm 39 and plug 4-39, may under the invention be located anywhere in the integral donor tube 20. For example, it may be located close to the bag 24, and with so much of the lower tube 23 as projects exteriorly of the bag being so short as to admit of the diaphragm or other closure being located in the region of or even interiorly of the wall of said bag 24. In such arrangement also and if employed the plug 4%) might be positioned just outside the bag, or in other words mounted with the surrounding stub tube as a projecting, closed and rescaling inlet fitting for the bag.

In the integral-separable donor tube coupling of FIG. 6 a pair of rubber or the like hubs or sleeves 42, 43 are received over the tube ends, and they are seized to the lengths 21, 23 by expanding over and contracting about their ends as stiffened by the inserted cannula 31, or by roughing or forming locking projections on both or the harder of said sleeves and tubes, or by inserting an adhesive bond therebetween, or by a combination of any or all of these. The hubs or sleeves 42, 43 further have annular, interference-fitted, male and female projections 42a, 43a, the female projection 42a engaging around and behind the male projection 43a and so sealing it against contamination such as might otherwise be wiped oii on the cannula 3i incident to the removal of the sleeve 42 therefrom.

The flexible elastic nature of the rubber or similar sleeves 4 2, 43, and as well the particular configuration of their interference-fitted projections 42a, 33a will be understood to permit the ready removal of tube length 23 from cannula 31 by the similar manual or pull-apart manipulation of the coupling as described for the embodiments previously considered.

Also with this interference-fitted sleeve form of the donor tube coupling, the lower tube length sleeve, herein male sleeve 43, may at or adjacent the end projection 4311 be continued as a solid wall 44, FIG. 8, whereby the lower tube length 23 has a self-sealing closure similarly as in FIG. 5. Thus and more particularly the insertion and withdrawal of the cannuia 3ll as already described will define in the sleeve plugging wall 44 a resiliently closed slit 44a, FIG. 9.

The upper tube length 21 and the inserted end 33 of a similar or smaller diametered cannula Sll may also be coupled as shown in FIG. 10, wherein sleeve 45 is ex- 6 panded over and so contracts the tube end about the cannula, may additionally be secured interiorly while being shaped exteriorly to define the manipulating hub of an integral, tube-end-fitted coupler or needle assembly. Such needle fitted upper length is employed with a lower tube 23 closed by a rubber or other self-sealing plug 46, which plug 46 has raised and/ or recessed formations 46a which deform conformantly and so interlock with the softer tube 2 3. The tube lengths 21, 23 are joined and the cannula 31 sealingly enclosed by a rubber or similar flexible elastic sleeve 47 expanded over the sleeve 45 and stretched over and also interlocking with the tube 23 as shown, and whereby when the donor tube is pulled apart the said sleeve 47 is withdrawn from the sleeve 4-5. The collecting tube opening, closing, and separating manipulation of the FIG. 10 form is otherwise as heretofore described in connection with FIG. 5.

In the form of FIGS. 11-13 the donor tube coupling comprises a hub 4-3 having a radial flange or shoulder 49 and a dependent neck 5%) interiorly recessed to receive the end of the upper tube 21 and also a rubber or other resilient sleeve 51 inserted and compressed between the tube end and the unpointed cannula end 32 on which the hub 48 is positioned. A funnel-like coupling member or housing 52 has an elongated tubular closed-ended portion 53 received over the cannula point 32 and a flaring or bowl portion releasably engaged or snapped over the hub shoulder 49. The housing 52 mounts also a sleeve 55 overlying the tubular part 53 and extending beyond it to engage and seize over the end of lower tube 23 as shown. The housing 52. is formed of rubber or other flexible elastic material whereby its bowl portion 54 may be axially closed. or collapsed as in FIG. 12 to advance cannula point 33 through the closed end of tubular part 53 and thereby to open the donor tube to the initial blood collection. To break the coupling, the sleeve 55' is first pulled away to withdraw cannula 32 from and leave resiliently closed or rescaling slit 53a in the end of said tubular part 53, and the elastic bowl portion 54 is then pulled or snapped 01f flange 49, all as shown in FIG. 13.

In fabricating or readying the integral bag and tube apparatus for use it is given a distilled water rinse to remove pyrogenic materials, and the rinse Water is eX pressed. Then the A.C.D., heparin, or other nutrient or preservative solution, if used, is supplied to and without also admitting air to the bag, following which the needle 22 and sheath or other suitable closure are then applied to the outer end of tube 26 to close and seal the entire system, and the equipment is sterilized with the container thus loaded and sealed.

In the obtaining and sampling of the blood in accordance. with this invention, a knot 26, FIG. 1, is loose tied in the lower length 23, the sealing sheath or similar closing and sealing means is withdrawn from the phlebotomy needle 22, and the needle point 22b is inserted into the vein of the donor.

It will be appreciated that when provided with the inner end closure, whether of the insertible-removable form of the FIG. 1 head 25, or of the fluid tight form of the FIG. 3 membrane 37, or of the self-sealing form of the FIG. 5 plug 46, the apparatus is conditioned or protected upon the opening of the donor tube outer end, for the mentioned phlebotomy or otherwise, against the ei'llux of the contained solution or influx of contaminated atmosphere through the donor tube.

It may be noted also that, if desired, the air may be substantially completely eliminated from the closed system, even with the use of the integral or membrane type of donor tube inner end closure, and so as both to eliminate liquid-gas interface from, and secure blood-solution contact immediately upon collecting flow into, the donor tube. Thus is accomplished by merely filling the donor tube 259 with the A.C.D. or the like from the outer end before applying the sealing sheath. The manipulation of the apparatus to that end with the bead 25 is even more simply to squeeze the bag with the donor tube held higher to force some of the solution back into the tube, and incidentally to express the air ahead of it, and then to close the tube at both ends by inserting the bead and applying the sheath. Following which, again, the equipment may be sterilized with the solution in.

Returning now to the description of the blood collection, the donor tube is then manipulated as necessary and from without to open it to fluid flow therethrough, as by milking down into the bag 24 the head 25 of FIG. 1, or by axially collapsing as in FIG. 4 the couplings of FIGS. 3, 5, 10 and 11, and thereby to allow the blood collection to proceed by gravity and/ or venous pressure.

In some cases only one pilot tube of uncitrated or clotted blood or serum may be needed, as where the collecting agency does its own serology and grouping tests and uses the clotted sample for those and the citrated sample of the donor tube for cross-matching; or alternatively the collecting agency may use the clotted sample for serology alone and draw on the citrated samples of the numbered segmented donor tube for the grouping and cross-matching tests. In either event and following collection of the blood into the bag 24 the donor tube 29 may be closed as by clamping adjacent thereto and the phlebotomy needle 22 withdrawn from the vein and immediately applied to an evacuated pilot or sample chamber or tube 56, FIGS. 1, l4, and 15, the needle stem 2219 being forced through the rubber or other resilient selfsealing tube closure or stopper 57. The pilot tube 56 is desirably and herein firmly or securely joined to the bag 24, as by adhesive straps or tapes 4-8, FIGS. 1 and 15. The uncitrated blood of the donor tube can then be drawn or stripped into the pilot tube and the donor tube closed as by knotting or clamping or sealing at the outer end. Subsequent release of the inner end clamp allows refluxing of the citrated blood from the bag back into the donor tube 20, and more particularly into the pilot chambers 27 which following such refluxing are individually closed by flatting and sealing the demarcations 23 as at 29, FIG. 15. Or one or more integral pilot chambers 27 may be formed by knotting or clamping of the tube 24' In the above mentioned cases it may be preferred, and for two or more separate samples of or a larger volume of the uncitrated blood it will be required, to manipulate the apparatus in accordance with the following technique, wherein when the desired amount of blood has been col lected in the bag 24 the knot 26 pulled white-tight as shown in FIGS. 7 and 15. It will be understood that when tightened thusly, or sufiiciently to express the fluid from its folds, the knot 26 forms an effective bacterial seal against contamination. Upon completion of the collection of the blood in the bag 24, and to obtain the pilot sample, the donor tube coupling 30 is separated or pulled apart and the cannula 31 is then inserted in the tube 56, by forcing point 32 through the rubber or other resilient self-sealing tube closure or stopper 57.

When during the above manipulation the cannula 31 is open for transit from the coupling 3b to the pilot tube 56 the upper tube 21 may be pinched or clipped to prevent spillage of blood, which would otherwise be induced by venous pressure. Once the fluid path has been reestablished as described the pinching is released or the clip removed and the pilot collection allowed to proceed under the same venous pressure or under the negative pressure of the evacuated pilot tube.

Upon completion of the collection of as many of the pilot tube 56 samples as are called for the phlebotomy needle 22 is withdrawn from the donors vein and the coupler tubing length 21 and its associated needles 22, 31 are discarded.

The blood in the lower tube length 23 is then refluxed into the bag 24 by stripping or compressing the tube to collapse the same and thereby express all of the blood whereby it may be mixed with the A.C.D. or other conditioning or preserving medium or solution with which the bag may be initially provided. Upon subsequent release of the collapsing force the blood will be drawn back into the tube 23 by its elastic or shape restoring tendency, and the blood so redrawn into the lower tube 23 will be in all respects duplicatory or representative of that remaining in the bag 24. The lower tube length 23 can then be closed and divided as by heat sealing at the demarcations 28 into segments or pilot tubes 27 in which are thereby individually sealed aliquots or samples which as just mentioned are representative of the main or parent donation or collection, and which are permanently and unmistakably identified therewith by the identifying markings or indica 27. As shown in FIG. 15 the seals 29 may be of a width such as admits of their dividing or cutting without opening into the segment to either side thereof.

Our invention is not limited to the particular embodiment thereof illustrated and described herein, and we set forth its scope in our following claims.

We claim:

1. In an apparatus for obtaining separate main donation and pilot sample blood volumes in sterile manner, an intergral flexible plastic collecting tube, said tube conditioned for separating in a length thereof, a flexible plastic blood container integrally joined to an end of said collecting tube, a donor needle mounted at the other end of the tube, and a stopper piercing cannula received in said tube and pointed at one end for applying to a stoppered pilot tube, said cannula positioned in said conditioned length such that said separating exposes said pointed end, said collecting tube initially providing a substantially uninterrupted path for the flow of blood from the donor needle to the flexible blood container.

2. The apparatus of claim 1 wherein the tube is conditioned for separating by weakening its wall so that it iay be pulled apart manually.

3. In an apparatus for the sterile collection of a blood donation and separately of a blood sample, a first tube length for connecting to a blood donor, a flexible plastic blood container for storing a blood donation, a second tube length for connecting said first length initially to said flexible plastic blood container, said second length integrally joined and inletting to said container, a pointed stopper piercing cannula inserted part way and secured in the end of said first tube length, the end of said second tube length drawn over the cannula portion projecting from said first tube length, and means integrally sealing between the ends of said first and second tube lengths, said sealing means permitting and visually signaling the pulling apart manually of said tube lengths to expose said projecting cannula portion for sterile connection to a sample storing means, said first and second tubes and cannula initially providing an uninterrupted path for the flow of blood from the blood donor to the flexible plastic blood container.

4. In an apparatus for the sterile collection of a blood donation and separately of a blood sample, which apparatus comprises a flexible plastic blood container for storing a blood donation, an integral donor tube provided at one end with a donor needle and inletting into said container at the other end, and a ball valve lodged in said other end of said donor tube, to prevent flow from and into said container; the improved donor tube which comprises two elongated sections of tubing, the first section of tubing provided at one end with a donor needle and at the other end with a pointed stopper piercing cannula inserted part way and secured in said other end, a second section of tubing the first end of which is drawn over the cannula portion projecting from the other end of said first section of tubing, the other end of said second section of tubing integrally joined and inletting into said container, and means integrally sealing between the ends of said first and second sections of tubing, said means permitting and visually signaling the pulling apart manually of said tube length to expose said projecting cannula portion, said first and second sections of tubing and cannula 9 initially providing an uninterrupted path for the flow of blood from the donor needle to the ball valve.

5. The apparatus of claim 4 in which said means comprises a pair of interlocking members provided at the other end of said first section of tubing and the first end of said second section of tubing, respectively.

References Cited in the file of this patent UNITED STATES PATENTS 10 2,847,995 Adams Aug. 19, 1958 2,896,619 Bellamy July 28, 1959 FOREIGN PATENTS 1,082,035 France June 16, 1954 1,107,207 France Aug. 3, 1955 OTHER REFERENCES Earl et al.: A Practical Method for the Aseptic Preparation of Human Platelet Concentrates Without Loss of Other Blood Elements, from New England Journal of Medicine, 254: 1132-1133 (June 14), 1956.

Gardner et al.: Platelet Transfers Utilizing Plastic Equipment, from I. Lab. and Clinical Medicine, February 1954, vol. 43, No. 2, pp. 196-207. 

1. IN AN APPARATUS FOR OBTAINING SEPARATE MAIN DONATION AND PILOT SAMPLE BLOOD VOLUMES IN STERILE MANNER, AN INTERGRAL FLEXIBLE PLASTIC COLLECTING TUBE, SAID TUBE CONDITIONED FOR SEPARATING IN A LENGTH THEREOF, A FLEXIBLE PLASTIC BLOOD CONTAINER INTEGRALLY JOINED TO AN END OF SAID COLLECTING TUBE, A DONOR NEEDLE MOUNTED AT THE OTHER END OF THE TUBE, AND A STOPPER PIERCING CANNULA RECEIVED IN SAID TUBE AND POINTED AT ONE END FOR APPLYING TO A STOPPERED PILOT TUBE, SAID CANNULA POSITIONED IN SAID CONDITIONED LENGTH SUCH THAT SAID SEPARATING EXPOSES SAID POINTED END, SAID COLLECTING TUBE INITIALLY PROVIDING A SUBSTANTIALLY UNINTERRUPTED PATH FOR THE FLOW OF BLOOD FROM THE DONOR NEEDLE TO THE FLEXIBLE BLOOD CONTAINER. 